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FluoroPharma Announces That Data From Its Phase II Clinical Trial of 18-F FCPHA (CardioPET) Was Presented at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting, June 10th in St. Louis, MO
Phase II Progress for CardioPET Is Encouraging; Expands on Data Presented at Mid-Winter Meeting
|By Marketwired .
|June 11, 2014 09:47 AM EDT
MONTCLAIR, NJ--(Marketwired - June 11, 2014) - FluoroPharma Medical, Inc. (OTCQB: FPMI), a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today announced that new Phase II trial data related to its CardioPET clinical trial was presented at the Society of Nuclear Medicine and Molecular Imaging Annual meeting (SNMMI), held in St. Louis, MO.
Data from a feasibility study on the quantification of myocardial perfusion in humans by PET/CT utilizing the fatty acid analogue 18F-FCPHA (CardioPET) were presented by the principal investigator, Olivier Gheysens, MD, PhD. According to Dr. Gheysens, "Our aim in this pilot study was to evaluate CardioPET uptake in our subject population, to address the potential for quantification. We analyzed the input functions and generated time-activity curves across 17 myocardial segments. Our analysis suggests that relative and quantitative blood flow measurements may be feasible with this tracer."
The study was conducted at the University Hospital Leuven, Belgium. Collaborators on this study include Olivier Gheysens, MD, PhD, Andrey Postnov, PhD, Johan Nuyts, PhD, Koen Van Laere, MD, PhD, DrSc (Department of Nuclear Medicine & Molecular Imaging, University Hospital Leuven, Belgium), Stefan Janssens, MD, PhD (Department of Cardiology, University Hospital Leuven, Belgium) and Manuel Cerqueira, MD (Department of Nuclear Medicine, Cleveland Clinic, Cleveland, Ohio USA.)
Thijs Spoor, Chairman and CEO of FluoroPharma commented, "The results are very encouraging for us, and builds on the safety and image quality data presented at the SNMMI Mid-Winter meeting. Quantification is an inherent strength of PET imaging. It provides physicians with additional information which may be helpful in making appropriate patient management decisions. We're now even more excited about the potential of CardioPET."
About CardioPET and the Phase II Clinical Trial
18-F FCPHA (CardioPET), one of FluoroPharma's first in class PET imaging products, is a perfusion and fatty acid uptake indicator, which is designed to be used as a cardiac imaging agent and may prove to be an effective alternative to currently available diagnostic tests. FluoroPharma believes its pharmacokinetic characteristics could be especially valuable in patients who are unable to exercise.
The Phase II clinical trial is an open label study designed to assess the safety and diagnostic performance of 18-F FCPHA (CardioPET) as compared to currently utilized SPECT myocardial perfusion imaging agents and angiography, the current "gold standard." This multicenter study is being conducted in Belgium.
About FluoroPharma Medical
FluoroPharma is a biopharmaceutical company engaged in the discovery and development of proprietary PET imaging products to evaluate cardiac disease at the cellular and molecular levels. The company has licensed technology from the Massachusetts General Hospital in Boston.
The company's goal is to enable personalized medicine through precision diagnostics that will help the medical community diagnose disease more accurately at the earliest stages, leading to more effective treatment, management and better patient outcomes.
FluoroPharma's initial focus is the development of breakthrough PET imaging agents and is advancing two products in clinical trials for assessment of acute and chronic forms of coronary artery disease. These first in class agents have been designed to rapidly target myocardial cells. Other products in development include agents for detection of inflamed atherosclerotic plaque in peripheral arteries, agents with the potential to image brain tissue affected by Alzheimer's disease and agents that could potentially be used for imaging specific cancers.
In addition to the United States, Europe and China, patents related to FluoroPharma's portfolio of imaging compounds have been issued in Japan, Canada, Australia, Finland, Portugal, Ireland and Mexico.
For more information on the company, please visit: www.fluoropharma.com
Except for historical information contained herein, the statements in this release are forward-looking. Forward-looking statements are inherently unreliable and actual results may differ materially. Examples of forward-looking statements in this news release include statements regarding FluoroPharma's research and development activities and anticipated operating results. Factors which could cause actual results to differ materially from these forward-looking statements include such factors as significant fluctuations in expenses associated with clinical trials, failure to secure additional financing, the inability to complete regulatory filings with the Food and Drug Administration, the introduction of competing products, or management's ability to attract and maintain qualified personnel necessary for the development and commercialization of its planned products, and other information that may be detailed from time to time in FluoroPharma's filings with the United States Securities and Exchange Commission. FluoroPharma undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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